Lovastatin (Page 6 of 6)

OVERDOSAGE

After oral administration of lovastatin to mice, the median lethal dose observed was >15 g/ m2.

Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdosage have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5 to 6 g.

Until further experience is obtained, no specific treatment of overdosage with lovastatin can be recommended.

The dialyzability of lovastatin and its metabolites in man is not known at present.

DOSAGE AND ADMINISTRATION

The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin tablets USP and should continue on this diet during treatment with lovastatin tablets USP (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin tablets USP should be given with meals.

Adult Patients

The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range of lovastatin is 10 to 80 mg/ day in single or two divided doses; the maximum recommended dose is 80 mg/ day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin tablets. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.

Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin tablets if cholesterol levels fall significantly below the targeted range.

Dosage in Patients taking Danazol, Diltiazem, Dronedarone or Verapamil

In patients taking danazol, diltiazem, dronedarone or verapamil concomitantly with lovastatin, therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/ day (see CLINICAL PHARMACOLOGY, Pharmacokinetics, WARNINGS, Myopathy/Rhabdomyolysis, PRECAUTIONS, Drug Interactions, Other Drug Interactions).

Dosage in Patients taking Amiodarone

In patients taking amiodarone concomitantly with lovastatin, the dose should not exceed 40 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions, Other Drug Interactions).

Adolescent Patients (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia

The recommended dosing range of lovastatin is 10 to 40 mg/ day; the maximum recommended dose is 40 mg/ day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines4 , CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.

Concomitant Lipid-Lowering Therapy

Lovastatin tablets USP are effective alone or when used concomitantly with bile-acid sequestrants (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).

Dosage in Patients with Renal Insufficiency

In patients with severe renal insufficiency (creatinine clearance <30 mL/ min), dosage increases above 20 mg/ day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).

HOW SUPPLIED

Lovastatin Tablets USP, 10 mg are light green colored, oval shaped, uncoated tablets, debossed with ‘LU’ on one side and ‘G01’ on the other side. They are supplied as follows:

NDC 68180-467-07 Bottles of 60

NDC 68180-467-09 Bottles of 90

NDC 68180-467-01 Bottles of 100

NDC 68180-467-03 Bottles of 1000

NDC 68180-467-05 Bottles of 5000

Lovastatin Tablets USP, 20 mg are light green colored, circular, beveled edged, uncoated tablets, debossed with ‘LU’ on one side and ‘G02’ on the other side. They are supplied as follows:

NDC 68180-468-07 Bottles of 60

NDC 68180-468-09 Bottles of 90

NDC 68180-468-01 Bottles of 100

NDC 68180-468-03 Bottles of 1000

NDC 68180-468-05 Bottles of 5000

Lovastatin Tablets USP, 40 mg are light green colored, circular, beveled edged uncoated tablets, debossed with ‘LU’ on one side and ‘G03’ on the other side. They are supplied as follows:

NDC 68180-469-07 Bottles of 60

NDC 68180-469-09 Bottles of 90

NDC 68180-469-01 Bottles of 100

NDC 68180-469-03 Bottles of 1000

NDC 68180-469-05 Bottles of 5000

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Lovastatin tablets must be protected from light and stored in a well-closed, light-resistant container.

1 Kantola, T, et al., Clin Pharmacol Ther 1998; 63(4): 397-402

3 Manson, J.M., Freyssinges,C.Ducrocq, M.B., Stephenson, W.P., Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproductive Toxicology. 10(6):439-446, 1996.

4 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.

Manufactured for

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by

Lupin Limited

Goa 403 722

INDIA

Revised: January 2021 ID#: 266228

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-467-07

LOVASTATIN TABLETS USP

10 mg

Rx only

Bottle of 60 Tablets

NDC 68180-467-07
LOVASTATIN TABLETS USP
10 mg
Rx only
Bottle of 60 Tablets
(click image for full-size original)

NDC 68180-468-07

LOVASTATIN TABLETS USP

20 mg

Rx only

Bottle of 60 Tablets

NDC 68180-468-07
LOVASTATIN TABLETS USP
20 mg
Rx only
Bottle of 60 Tablets
(click image for full-size original)

NDC 68180-469-07

LOVASTATIN TABLETS USP

40 mg

Rx only

Bottle of 60 Tablets

NDC 68180-469-07
LOVASTATIN TABLETS USP
40 mg
Rx only
Bottle of 60 Tablets
(click image for full-size original)
LOVASTATIN lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
BUTYLATED HYDROXYANISOLE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color GREEN (light green) Score no score
Shape OVAL (oval) Size 6mm
Flavor Imprint Code LU;G01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-467-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-467-07 60 TABLET in 1 BOTTLE None
3 NDC:68180-467-01 100 TABLET in 1 BOTTLE None
4 NDC:68180-467-03 1000 TABLET in 1 BOTTLE None
5 NDC:68180-467-05 5000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078296 03/14/2008
LOVASTATIN lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-468
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
BUTYLATED HYDROXYANISOLE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color GREEN (light green) Score no score
Shape ROUND (circular, beveled edged) Size 6mm
Flavor Imprint Code LU;G02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-468-07 60 TABLET in 1 BOTTLE None
2 NDC:68180-468-09 90 TABLET in 1 BOTTLE None
3 NDC:68180-468-01 100 TABLET in 1 BOTTLE None
4 NDC:68180-468-03 1000 TABLET in 1 BOTTLE None
5 NDC:68180-468-05 5000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078296 11/01/2007
LOVASTATIN lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-469
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
BUTYLATED HYDROXYANISOLE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color GREEN (light green) Score no score
Shape ROUND (circular, beveled edged) Size 8mm
Flavor Imprint Code LU;G03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-469-07 60 TABLET in 1 BOTTLE None
2 NDC:68180-469-09 90 TABLET in 1 BOTTLE None
3 NDC:68180-469-01 100 TABLET in 1 BOTTLE None
4 NDC:68180-469-03 1000 TABLET in 1 BOTTLE None
5 NDC:68180-469-05 5000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078296 11/01/2007
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-467), MANUFACTURE (68180-468), MANUFACTURE (68180-469), PACK (68180-467), PACK (68180-468), PACK (68180-469)

Revised: 01/2021 Lupin Pharmaceuticals, Inc.

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